None listed
Conditions
Interventions
Drug : It is a single-arm, open-label study.
Drug: enfed Tablet
dose: 0.5 mg
Frequency: 1 time per day
Time Frame: 6 months
route: Oral
Sponsors
GangNeung Asan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women over the age of 19 and under the age of 75 2) Child-Pugh score <8 3) Patients with confirmed hepatitis B s antigen (HBsAg) positivity for at least 6 months 4) Hepatitis B e-antigen (HBeAg) positive or negative patients 5) Patients who have been receiving 0.5 mg of baracrud tablet (ETV) alone for more than 24 weeks for chronic hepatitis B 6) Subjects with confirmed viral suppression effect of ETV (HBV DNA < 60 IU/mL) and judged to require ETV monotherapy for more than 48 weeks 7) Those who voluntarily agreed to participate in clinical trials and signed a written informed consent form
Exclusion criteria
Exclusion criteria: 1) Patients with confirmed co-infection with other hepatitis viruses (hepatitis C or D virus) or human immunodeficiency virus (HIV) 2) Patients with a history of alcohol abuse (40g/day) or illegal drug abuse 3) Subjects who have received chronic hepatitis B medications other than baracrud tablets (ETV) within 12 months prior to screening or who have received other immunomodulatory treatments 4) Patients who have any of the following items (a) Ascites, variceal bleeding, hepatic encephalopathy ? Child-Pugh score = 8 5) Patients requiring use of systemic prednisolone or immunosuppressive drugs (including chemotherapeutic agents) of more than 20 mg per day for more than 2 weeks 6) Patients who have undergone solid organ transplantation or bone marrow transplantation 7) Patients hypersensitive to entecavir 8) Patients who have received 0.5mg of enfed tablet within 12 weeks prior to screening 9) History of liver cancer diagnosis within 5 years prior to screening 10) Patients with a history of other malignancies except liver cancer [However, patients who are judged to have no evidence of disease and have not undergone chemotherapy or surgical treatment within the last 3 years, and basal cell carcinoma or squamouscell carcinoma of the skin, can participate in the trial if they are judged to be 'cured' at the discretion of the investigator.] 11) Participating in another clinical trial in which the drug is administered [However, if the clinical trial is not related to antiviral drugs (prohibited drugs) or immunosuppressive drugs, it is possible to participate.] 12) Pregnant or lactating women, or patients who are planning to become pregnant 13) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 14) In addition, those who are clinically judged by the principal investigator to be difficult for the clinical trial subject to conduct the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects maintained at HBV DNA < 60 IU/mL | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with serum HBV DNA < 60 IU/mL at baseline who are suppressed to serum HBV DNA < 29 IU/mL at 24 weeks | — |
Countries
Korea, Republic of
Contacts
Public ContactGab Jin Cheon
GangNeung Asan Hospital
Outcome results
None listed